Responsable Affaires Réglementaires - spécialiste produits combinés

JR France; Lille; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

A leading company in the pharmaceutical sector is seeking a Senior Regulatory Affairs Consultant to support clients in the development and management of drug-delivery devices. The role involves leading regulatory projects, collaborating with R&D teams, and ensuring compliance with EU and US regulations. Ideal candidates will have extensive experience in Regulatory Affairs, strong project management skills, and a passion for continuous learning.

Qualifications

• 8–12 years of relevant experience in Regulatory Affairs and R&D.
• Experience with audits and inspections.

Responsabilités

• Leading regulatory strategy development for drug-delivery devices.
• Managing communications with notified bodies and health authorities.

Connaissances

Regulatory Affairs

Project Management

Stakeholder Management

Quality Management Systems

Fluency in English

Formation

University degree in Biomedical Engineering

University degree in Pharmacy

Outils

ISO 13485

MDR

21 CFR 820

ISO 14971

Description du poste

Job Description:

As a Senior Regulatory Affairs (RA) Consultant, you will play a pivotal role in supporting pharmaceutical and medical device clients in the development, submission, and lifecycle management of drug-delivery devices and combination products. You will lead and guide various regulatory projects, providing expert advice on strategies, classifications, and pathways, while collaborating closely with R&D teams to develop new products or manage existing ones. Your responsibilities include:

1. Leading and implementing regulatory strategy development for drug-delivery devices and combination products.
2. Providing guidance on regulatory classification and submission pathways for the EU (MDR, CE Marking) and the US (FDA, 510(k), PMA, NDA, BLA, ANDA).
3. Supporting R&D teams from design control to quality management, ensuring compliance with applicable standards and frameworks.
4. Collaborating with internal stakeholders to compile dossiers and technical documentation for submissions.
5. Drafting and reviewing device sections of eCTD modules for applications.
6. Managing communications with notified bodies and health authorities, including audits and inspections.
7. Mentoring team members and contributing to internal training and development.

Your Profile:

You are an independent, proactive professional passionate about regulatory projects, thriving in dynamic environments, and committed to continuous learning and knowledge sharing. You should possess:

• 8–12 years of relevant experience in Regulatory Affairs and R&D related to drug-delivery devices and combination products under EU and US frameworks.
• Experience with Quality Management Systems (ISO 13485, MDR, 21 CFR 820, ISO 14971).
• Expertise in device development under design controls and technical standards.
• Ability to manage projects and stakeholder relationships independently.
• Experience with audits and inspections.
• University degree in Biomedical Engineering, Pharmacy, or related fields.
• Fluency in English; French is a plus.